A guide to clinical trials for cancer

Clinical trials for cancer look at ways to:

• Prevent cancer
• Screen or test for cancer
• Treat or manage cancer
• Reduce symptoms or side effects of cancer or cancer treatments

A clinical trial will recruit many people to participate. During the study, each group of people will receive a different test or treatment. Some will get the new treatment being tested. Others will get standard treatment. The researchers will collect the results to see what works best.

Current cancer medicines, tests, and treatments used by most health care providers have been tested through clinical trials.

The decision to join a clinical trial is a personal one. It is a decision you have to make based on your values, goals, and expectations. Plus, there are benefits and risks when you join a trial.

Some of the benefits include:

• You may receive a new treatment that is not yet available to other people.
• You may receive treatment that is better than what is currently available.
• You will receive close attention and monitoring by your providers.
• You will help researchers understand your cancer and learn better ways to help other people with the same cancer.

Some of the potential risks include:

• You may experience side effects.
• The new treatment may not work for you.
• The new treatment may not be as good as standard treatment.
• You may need more office visits and more tests.
• Your insurance may not pay for all of your costs in a clinical trial.

There are strict federal rules in place to protect your safety during a clinical trial. Safety guidelines (protocols) are agreed to before the study begins. These guidelines are reviewed by health experts to make sure that the study is based on good science and the risks are low. Clinical trials are also monitored during the entire study.

Before you join a clinical trial, you will learn about the safety guidelines, what is expected of you, and how long the study will last. You will be asked to sign a consent form saying that you understand and agree to the way the study will be run and the potential side effects.

Before you join a trial, make sure you look into which costs are covered. Routine cancer care costs are often covered by health insurance. You should review your policy and contact your health plan to make sure. Often, your health plan will cover most routine office visits and consults, as well as tests done to monitor your health.

Research costs, such as the study medicine, or extra visits or tests, may need to be covered by the research sponsor. Also keep in mind that extra visits and tests may mean additional cost to you in lost work time and daycare or transportation costs.

Each clinical study has guidelines about who can join. These are called eligibility criteria. These guidelines are based on what questions the researchers are trying to answer. Studies often try to include people who have certain things in common. This can make it easier to understand the results. So you may be able to join only if you have cancer at a certain stage, are older or younger than a certain age, and do not have other health problems.

If you are eligible, you can apply to be in the clinical trial. Once accepted, you become a volunteer. This means that you may quit at any time. But if you feel you want to quit, be sure you talk it over with your provider first.

Trials are done in many places, such as:

• Cancer centers
• Local hospitals
• Medical group offices
• Community clinics

You can find clinical trials listed on the website of the National Cancer Institute (NCI) -- www.cancer.gov/about-cancer/treatment/clinical-trials. It is a part of the National Institutes of Health, the United States government research agency. Many of the clinical trials run across the country are sponsored by the NCI.

If you are interested in joining a clinical trial, talk with your provider. Ask if there is a trial in your area related to your cancer. Your provider can help you understand the type of care you will receive and how the trial will change or add to your care. You can also go over all of the risks and benefits to decide whether joining a trial is a good move for you.

Intervention study - cancer

American Cancer Society website. Clinical trials. www.cancer.org/treatment/treatments-and-side-effects/clinical-trials.html. Accessed October 19, 2022.

National Cancer Institute website. Clinical trials information for patients and caregivers. www.cancer.gov/about-cancer/treatment/clinical-trials. Accessed October 19, 2022.

National Institutes of Health website. Clinical Trials.gov. www.clinicaltrials.gov. Accessed October 19, 2022.

Updated by: Todd Gersten, MD, Hematology/Oncology, Florida Cancer Specialists & Research Institute, Wellington, FL. Review provided by VeriMed Healthcare Network. Also reviewed by David C. Dugdale, MD, Medical Director, Brenda Conaway, Editorial Director, and the A.D.A.M. Editorial team.